ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.

NCT03252743 | Completed

• 1 other identifier: FGID IMP 2017
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This open trial aims to evaluate feasibility and preliminary effectiveness of an internet-delivered CBT-program for children and adolescents with functional gastrointestinal disorders when implemented in regular care.

Conditions

Functional Gastrointestinal Disorders; Irritable Bowel Syndrome; Dyspepsia; Functional Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).

  Change in global gastrointestinal symptoms from baseline to 10 weeks.

  Baseline to 10 weeks.

Secondary Outcomes (17)

• Pain intensity (Faces Pain rating scale)

  Baseline to 10 weeks

• Pain intensity (Faces Pain rating scale)

  Baseline to 5 months.

• Pain intensity (Faces Pain rating scale)

  Baseline to 8 months.

• Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).

  Baseline to 5 months.

• Global gastrointestinal symptoms (CSI-24: subscale 7 items on GI-symptoms).

  Baseline to 8 months.

Other Outcomes (3)

• Parental responses to children´s symptom behavior (ARCS)

  Baseline to 10 weeks.

• Parental responses to children´s symptom behavior (ARCS)

  Baseline to 5 months.

• Parental responses to children´s symptom behavior (ARCS)

  Baseline to 8 months.

Study Arms (1)

Internet-delivered CBT

EXPERIMENTAL

Exposure-based internet-delivered CBT with ten weekly modules distributed over the internet during ten weeks, and weekly therapist support over the internet.

Behavioral: Exposure-based internet-delivered CBT

Interventions

Exposure-based internet-delivered CBT BEHAVIORAL

The main target in treatment is exposure for abdominal symptoms by reducing avoidance and provoking symptoms. Participants are encouraged to gradually increase the difficulty by combining multiple challenges. The parents are taught how to reduce the risk for reinforcement of children's symptom behavior, and to support their child to complete the treatment. All treatment content is delivered over the internet, containing texts, videos, audio-files and examples. The modules are unlocked sequentially as participants worked their way through the treatment. Therapist support consists primarily of encouragement of any progress made in the treatment and support to find individual exercises.

Internet-delivered CBT

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Fulfilling Rome IV-criteria for irritable bowel syndrome, functional dyspepsia or functional abdominal pain with a written statement from patient's physician confirming a diagnosis.
• Stable psychotropic medication for at least 1 month.

You may not qualify if:

• concurrent serious medical conditions.
• a psychiatric diagnosis, judged to be a more important treatment target than the abdominal pain.
• on-going structured psychological treatment.
• on-going abuse or severe parental psychiatric illness in the family.
• lack of regular internet-access.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Department of Clinical Neuroscience, Karolinska Institutet

Stockholm, Sweden

Location

Related Links

• Research project homepage for studies on ICBT for pediatric FGIDs (in Swedish).

MeSH Terms

Conditions

Gastrointestinal Diseases; Irritable Bowel Syndrome; Dyspepsia

Condition Hierarchy (Ancestors)

Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marianne Bonnert, PhD

  Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Open trial without control group to test feasibility and evaluate preliminary effects.

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 17, 2017
• Study Start: September 1, 2017
• Primary Completion: June 17, 2018
• Study Completion: December 18, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

SE (1)